Baseline Lung Function Had No Effect on Long-Term Reduction in FVC Decline With Nintedanib in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Abstract

SESSION TITLE: Diffuse Lung Disease 2 SESSION TYPE: Original Investigation Poster PRESENTED ON: Wednesday, November 1, 2017 at 01:30 PM - 02:30 PM PURPOSE: In two Phase III INPULSIS trials, nintedanib reduced disease progression by significantly reducing the annual rate of decline in forced vital capacity (FVC) in patients with IPF. Patients who completed the 52-week treatment period and follow-up visit in the INPULSIS trial were eligible to receive open-label nintedanib in an extension trial known as INPULSIS-ON. Patients treated with placebo in INPULSIS initiated nintedanib in INPULSIS-ON; patients treated with nintedanib in INPULSIS continued nintedanib in INPULSIS-ON. We investigated whether FVC at baseline of INPULSIS-ON influenced the effect of nintedanib on the long-term decline in FVC. METHODS: The annual rate of decline in FVC over 96 weeks in INPULSIS-ON was assessed in subgroups defined by FVC ≤70% versus >70% predicted and ≤90% versus >90% predicted at baseline of INPULSIS-ON. All available FVC measurements between baseline and week 96 of INPULSIS-ON were used to calculate the slope of FVC decline. Analyses were descriptive and based on a data snapshot in October 2015. RESULTS: Of 807 patients who completed the INPULSIS trials, 734 patients (91%) participated in INPULSIS-ON. At baseline of INPULSIS-ON, mean (SD) age was 67.2 (7.8) years and mean (SD) FVC was 76.2 (19.1) % predicted. The adjusted annual rate (SE) of decline in FVC over 96 weeks in all patients in INPULSIS-ON was −117.8 (6.8) mL/year, which was of a similar magnitude to the adjusted annual rate (SE) of decline in FVC over 52 weeks in patients treated with nintedanib in INPULSIS (−113.6 [11.0] mL/year). In patients with FVC ≤70% versus >70% predicted at baseline of INPULSIS-ON, the adjusted annual rates (SE) of decline in FVC over 96 weeks in INPULSIS-ON were −132.9 (12.5) mL/year versus −109.1 (8.2) mL/year, respectively. In patients with FVC ≤90% versus >90% predicted at baseline of INPULSIS-ON, the adjusted annual rates (SE) of decline in FVC over 96 weeks in INPULSIS-ON were −125.8 (8.2) mL/year versus −98.7 (12.3) mL/year, respectively. CONCLUSIONS: Results from INPULSIS-ON demonstrated a consistent annual rate of decline in FVC in patients with IPF treated with nintedanib irrespective of FVC at baseline of INPULSIS-ON. CLINICAL IMPLICATIONS: These results support the long-term efficacy of nintedanib in reducing disease progression in patients with IPF, irrespective of the degree of lung function impairment at baseline. Primary source of funding: Boehringer Ingelheim. DISCLOSURE: David Hotchkin: Consultant fee, speaker bureau, advisory committee, etc.: Received travel funds from Boehringer Ingelheim to attend study (BI 1199.247) launch in February 2017 Wibke Stansen: Employee: Employee of Boehringer Ingelheim Pharma GmbH & Co. KG Manuel Quaresma: Employee: Employee of Boehringer Ingelheim Pharma GmbH & Co. KG Bruno Crestani: Other: Reports honorarium, travel grant support, or research grants from Apellis, Astra-Zeneca, Boehringer Ingelheim, CARDIF, Intermune/Roche, LVL, MedImmune, and Sanofi The following authors have nothing to disclose: Mitchell Kaye, Paul Mohabir, Kevin Gibson No Product/Research Disclosure Information